Emergency Use Authorization (EUA) - FAQs:
- Do the FDA's Emergency Use Authorizations (EUA) for antiviral drugs (Tamiflu and Relenza) cover their use for both prevention and treatment?
- Do the Emergency Use Authorizations (EUA) for the antiviral drug products Relenza and Tamiflu cover only products in the Strategic National Stockpile (SNS) or do they cover the state and local stockpiles and private sector stockpiles?
- Do the Emergency Use Authorizations (EUA) for Tamiflu and Relenza cover regular pharmacy prescriptions?
- Do the Emergency Use Authorizations (EUA) for antivirals allow hospitals without outpatient pharmacies to dispense Tamiflu and Relenza?
- Under the FDA Emergency Use Authorizations (EUA) for Tamiflu and Relenza, what information should be given to a patient?
- Under the FDA's Emergency Use Authorizations (EUA) for Tamiflu and Relenza, what does it mean to make available medication information through appropriate means?
- In the Emergency Use Authorizations (EUA) for Tamiflu and Relenza, what kind of additional information, which is consistent with the fact sheets, can be provided by the CDC and state or local authorities?
- Why does the Emergency Use Authorization (EUA) for Tamiflu state that it covers Strategic National Stockpile assets and those authorized under SLEP, but the EUA for Relenza does not make the same statement?
- Do the Emergency Use Authorizations (EUA) override state guidelines regarding dispensing and storage of Tamiflu and Relenza in a public health emergency?
